Black Box Warning

In the United States, a black box warning (or “black label warning” or “boxed warning”) is the sternest warning that the Food and Drug Administration can issue for a medication and still allow it to remain on the market. A black box warning will appear on the medication’s label, insert and all other literature associated with the drug, such as magazines advertisements. The warning is named for and easily distinguished by the black border that surrounds its text and will contain a concise summary of the risks associated with taking the medication.

The FDA will issue a black box warning for a drug when medical studies indicate that the drug carries a significant risk of serious undesirable effects, such as a fatal, life-threatening or permanently disabling adverse reaction, when compared to the potential benefit of the drug. A black box warning can also be issued when adverse reactions can be prevented or reduced in frequency and severity by proper use of the drug. For example, a warning may be issued for a medication that is safe to treat adults, but not children.

A complete list of medications with black box warnings may be found at BlackBoxRx.com, and the official FDA website contains medication guides for many of the listed drugs. However, it is also important to maintain an open dialogue with your physician if you are concerned about the potential side effects of a drug, as it is crucial that both you and your doctor understand the potential benefits and risks of treatment.